(111 days)
Not Found
No
The description focuses on the physical characteristics and mechanical function of the embolization coils and delivery system, with no mention of AI or ML.
Yes
The device is intended for endovascular embolization of intracranial aneurysms, which involves treating a medical condition.
No
The device description indicates that the MicroPlex Coil System is used for endovascular embolization of intracranial aneurysms, which is a treatment procedure, not a diagnostic one.
No
The device description clearly states that the device is fabricated from a platinum alloy wire and is provided attached to a Delivery Pusher, indicating it is a physical medical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the endovascular embolization of intracranial aneurysms. This is a therapeutic procedure performed within the body to treat a medical condition.
- Device Description: The device is a physical coil system designed to be implanted into an aneurysm.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
This device is a medical device used for treatment, not for diagnostic testing of samples outside the body.
N/A
Intended Use / Indications for Use
The MicroVention MicroPlex Coil System (MCS) is intended for endovascular embolization of intracranial aneurysms that are considered by the treating neurosurgical team to be at very high risk for management by traditional operative techniques because of their morphology, their location or the patient's general medical condition, or are inoperable.
Product codes
HCG
Device Description
The MicroVention MicroPlex Coils are available in two versions: (1) Complex-shaped configurations, and (2) helically-shaped coil configurations of various diameters and dimensions. These embolization coils are fabricated from a platinum alloy wire, which is first wound into a primary coil, and then formed into the secondary complex or helical shape.
The MicroPlex Coils are provided attached to a Delivery Pusher. The MicroPlex Coil is detached from the Delivery Pusher by applying pressure force, with radiographic contrast media, at the proximal end of the Delivery Pusher. Once the embolization coil is detached, the Delivery Pusher is then removed from the microcatheter and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracranial aneurysms
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Treating neurosurgical team
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The non-clinical tests performed on the MicroVention MicroPlex Coil System (MCS) were based upon the intended use of the device, the performance of the predicate devices (GDC and Micrus) and an analysis of the failures of the predicate device (as based upon a review of applicable MDR reports). This testing included tensile strength, coil detachment, biocompatibility, and clinical simulation testing in animals.
This extensive body of testing has demonstrated that the MicroVention MicroPlex Coil System has performance substantially equivalent to that of the predicate devices, the Micrus Microcoil Delivery System and the Boston Scientific Target Therapeutics GDC system.
Key Metrics
Not Found
Predicate Device(s)
K002056, K993417, K991139, K951256
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5950 Neurovascular embolization device.
(a)
Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.(b)
Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).
0
MicroVention, Inc. MicroPlex Coil System
OCT 2 9 2001
KO12145
Premarket Notification Confidential
SECTION 11
SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
-
- Submitter's name, address, telephone number, contact person, and date summary prepared;
- a. Submitter's Name: Robert Rosenbluth President and CEO MicroVention, Inc. 72 Argonaut Aliso Viejo, CA 92656
- Jay Lenker, Ph.D. b. Contact Person: Vice President, Scientific Affairs MicroVention, Inc. 72 Argonaut Aliso Viejo, CA 92656
- July 2, 2001 Date Summary Prepared: C.
-
- Name of device, including trade name and classification name:
- Trade/Proprietary Name: MicroVention MicroPlex Coil System (MCS) a.
- b. Classification Name: Device, Artificial Embolization Regulation Number: 882.5950 Product Code HCG Device Class: III
1
3. Identification of the predicate device or legally marketed device or devices to which substantial equivalence is being claimed:
| Predicate
Devices | Company | Description | Clearance
Date |
|----------------------|---------------------|---------------------------------------------------------------|-------------------|
| K002056 | Micrus Corporation | Micrus Microcoil Delivery System | 1/11/2001 |
| K993417 | Target Therapeutics | GDC-10 and GDC-18 Guglielmi
Detachable Coil (3D Shape GDC) | 1/21/2000 |
| K991139 | Target Therapeutics | Guglielmi Detachable Coil (GDC) | 12/22/1999 |
| K951256 | Target Therapeutics | Detachable Platinum Coil (Guglielmi
Detachable Coil) | 9/8/1995 |
4. A description of the device that is the subject of the 510(k), including explanation of how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The MicroVention MicroPlex Coils are available in two versions: (1) Complex-shaped configurations, and (2) helically-shaped coil configurations of various diameters and dimensions. These embolization coils are fabricated from a platinum alloy wire, which is first wound into a primary coil, and then formed into the secondary complex or helical shape.
The MicroPlex Coils are provided attached to a Delivery Pusher. The MicroPlex Coil is detached from the Delivery Pusher by applying pressure force, with radiographic contrast media, at the proximal end of the Delivery Pusher. Once the embolization coil is detached, the Delivery Pusher is then removed from the microcatheter and discarded.
5. Statement of intended use:
The MicroVention MicroPlex Coil System (MCS) is intended for endovascular embolization of intracranial aneurysms that are considered by the treating neurosurgical team to be at very high risk for management by traditional operative techniques because of their morphology, their location or the patient's general medical condition, or are inoperable.
2
MicroVention, Inc. MicroPlex Coil System
Statement of how the technological characteristics of the device compare to 6. those of the predicate or legally marketed device.
The MicroVention MicroPlex Coil System (MCS) has the same technological characteristics as the predicate Micrus Corporation and BSC Target Therapeutics GDC coils. Both the materials of fabrication and the configuration of the coils are the same or very similar, with both the MicroVention and the predicate devices available in a variety of diameters and lengths to allow treatment of a variety of aneurysm sizes. Coil delivery is also similarly accomplished for the MicroVention MCS and for the predicate devices. The MicroVention MCS differs from the predicate devices with regard to the method used for coil detachment. Detachment of the MCS is effected by means of a detachment control syringe, which creates pressure at the proximal end of the Delivery Pusher. In contrast, the Micrus embolization coil is detached by heat-initiated shearing of a polyethylene fiber, and the Target Therapeutics GDC coils are released by means of electrolytic corrosion of a positioning wire near the junction of the coil.
Brief summary of nonclinical tests and results: 7.
The non-clinical tests performed on the MicroVention MicroPlex Coil System (MCS) were based upon the intended use of the device, the performance of the predicate devices (GDC and Micrus) and an analysis of the failures of the predicate device (as based upon a review of applicable MDR reports). This testing included tensile strength, coil detachment, biocompatibility, and clinical simulation testing in animals.
This extensive body of testing has demonstrated that the MicroVention MicroPlex Coil System has performance substantially equivalent to that of the predicate devices, the Micrus Microcoil Delivery System and the Boston Scientific Target Therapeutics GDC system.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
OCT 2 9 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Vin Cutarelli Vice President Regulatory Affairs and Quality Assurance MicroVention, Inc. 72 Argonaut Aliso Viejo, California 92656
Re: K012145
Trade/Device Name: MicroVention MicroPlex Coil System (MCS) Regulation Number: 882.5950 Regulation Name: Artificial Embolization Device Regulatory Class: III Product Code: HCG Dated: September 4, 2001 Received: September 26, 2001
Dear Mr. Cutarelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave ro rowed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are based or to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Vin Cutarelli
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Lus-Wall, M
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Page 1 of 1
510(k) Number (if known): K012 145
Device Name: MicroPlex™ Coil System (MCS)
Indications for Use:
The MicroVention MicroPlex Coil System (MCS) is intended for endovascular embolization of those intracranial aneurysms that, because of their morphology, their location or the patient's general medical condition, are considered by the treating neurosurgical team to be very high risk for management by traditional operative techniques, or inoperable.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use (Optional Format 1-2-96)
SL
(Division Sign-Off)
(Division Sigm-OII)
Division of General, Restorative
Division of General Devices Division of General, Devices
and Neurological Devices 510(k) Numb
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